Cleared Special

G+ SYSTEM (K101344) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101344 · Glytec, LLC (Formally Known AS Glucotec, Inc.) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
46d
Days
Class 2
Risk

K101344 is an FDA 510(k) clearance for the G+ SYSTEM. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Glytec, LLC (Formally Known AS Glucotec, Inc.) (Simpsonville, US). The FDA issued a Cleared decision on June 28, 2010 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Glytec, LLC (Formally Known AS Glucotec, Inc.) devices

Submission Details

510(k) Number K101344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2010
Decision Date June 28, 2010
Days to Decision 46 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.